Immune System Stimulation by Probiotic Food Supplementation

Immune System Stimulation by Probiotic Food Supplementation: a Double-blind, Randomized, Controlled, Parallel-designed, Prospective Trial

The purpose of this study is to investigate the effects of a probiotic supplementation on adult volunteers with having caught the common cold more than 4 times in the past year. This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Subjects received a probiotic drink containing probiotics of Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431® (108CFU/ml) and Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without probiotics for a 12-week study period.

The incidence of flue and cold during the study period were compared between study groups.

Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.

Study Overview

• Status: Completed
• Conditions: Flu Symptom
• Intervention / Treatment: Dietary supplement: Weiquan Yogurt with probiotics; Dietary supplement: Weiquan Yogurt without probiotics

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male or female between 25 to 45 years old;
• having caught the common cold or flu at least 4 to 6 times in the past calendar year;
• signed the informed consent forms before entering the study;
• fully understood the risks and potential benefits in participating this study.

Exclusion Criteria:

• were diagnosed with the decreased immunity caused by any diagnosed chronic illness;
• having any gastrointestinal illness with medical treatment at the time of being enrolled;
• having any diagnosed respiratory illness with similar symptoms as the common cold and flu;
• currently taking any pain killer drug;
• having received any vaccine for the upper respiratory infection within 6 months before enrollment;
• having received any purgative drug or digestion related drug within 2 weeks before enrollment;
• having taken any dairy product containing prebiotics and probiotics within 10 days before enrollment;
• currently taking any preventive drug for upper respiratory infection;
• having received any drug which has impact with the immune system such as antibiotics within 3 months before enrollment;
• alcoholic or addicted to any drug;
• pregnant or breastfeeding mothers;
• having participated another clinical trial within 3 months before enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weiquan Yogurt with probiotics; Weiquan Yogurt with probiotics contained Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacillus casei 431® (108 CFU/ml) and Lactobacillus fermentum PCC® (106 CFU/ml)	Dietary supplement: Weiquan Yogurt with probiotics; 150 ml daily consumption for a total of 12 weeks
Placebo Comparator: Weiquan Yogurt without probiotics; Weiquan Yogurt devoid of probiotics, but otherwise similar to the experimental product.	Dietary supplement: Weiquan Yogurt without probiotics; 150 ml daily consumption for a total of 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of flue symptoms during the study	Body temperature≥38.0℃, and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.	end of week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cold symptoms during the study	Body temperature<38.0℃, and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.	end of week 12
Number of accumulated days of having cold symptoms during the study	The total number of days of having one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite during the 12 week study period.	End of week 12
Serum IFN-γ concentration	Interferon gamma (unit: pg/ml)	Baseline, end of week 12
Serum IL-4 concentration	Interleukin 4 (unit: ng/ml)	Baseline, end of week 12
Serum IL-10 concentration	Interleukin 10 (unit: pg/ml)	Baseline, end of week 12
Serum IgA concentration	Immunoglobulin A (unit: g/L)	Baseline, end of week 12
Serum IgG concentration	Immunoglobulin G (unit: g/L)	Baseline, end of week 12
Serum IgM concentration	Immunoglobulin M (unit: g/L)	Baseline, end of week 12
Fecal sIgA concentration	Secretory Immunoglobulin A (unit: ng/ml)	Baseline, end of week 12

Collaborators and Investigators

• Sponsor: Hangzhou Wei Chuan Foods Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2016
• Primary Completion (Actual): April 10, 2016
• Study Completion (Actual): May 2, 2016

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 15-SC-09-WQ-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No